UMIN-CTR Clinical Trial

Basic information
Public title	Prospective randomized trial on Pemafibrate versus omega-3-acid ethyl in patients with treated hypertriglyceridemia
Acronym	Prospective randomized trial on Pemafibrate versus omega-3-acid ethyl in patients with treated hypertriglyceridemia
Scientific Title	Prospective randomized trial on Pemafibrate versus omega-3-acid ethyl in patients with treated hypertriglyceridemia
Scientific Title:Acronym	Prospective randomized trial on Pemafibrate versus omega-3-acid ethyl in patients with treated hypertriglyceridemia
Region	Japan

Condition
Condition	Hypertriglyceridemia
Classification by specialty	Cardiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is a comparative study of Pemafibrate and omega 3 fatty acid ethyl for hypertriglyceridemia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	TG
Key secondary outcomes	LDL,HDL,T-cho,sCr,eGFR Remnant-Like Particle,Apo A-I,B,E,fatty acid fractionation,urinary albumin,cystitis C,oxidized LDL Cartotid echo,ABI,FMD

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Pemafibrate 0.2mg/day
Interventions/Control_2	omega 3 fatty acid ethyl 2g/day
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients being treated for hypertriglyceridemia
Key exclusion criteria	sCr>1.5mg/dL(treating with statin) sCr>2.5mg/dL(untreating with statin) Patients who were deemed not appropriate to participate in this study by doctor
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Sezai
Organization	Nihon University School of Medicine
Division name	Department of Cardiovascular Surgery
Zip code	1738610
Address	30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Email	asezai.med@gmail.com

Public contact
Name of contact person	1st name Mitsue Middle name Last name Akiyama
Organization	Sekino Laboratory
Division name	Department of Research
Zip code	1710014
Address	3-28-3 ikebukuro, Toshima-ku, Tokyo, Japan
TEL	03-3986-5501
Homepage URL
Email	skn-np@sekino-hospital.com

Sponsor
Institute	Sekino Hospital
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Sekino Laboratory
Address	3-28-3 ikebukuro, Toshima-ku, Tokyo, Japan
Tel	03-3986-5501
Email	skn-np@sekino-hospital.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	関野病院（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 06 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 10 Month 01 Day
Date of IRB	2018 Year 10 Month 22 Day
Anticipated trial start date	2019 Year 06 Month 20 Day
Last follow-up date	2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 19 Day
Last modified on	2021 Year 04 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042033